None listed
Conditions
Interventions
Intervention1: VISPO capsule: 4 capsules after breakfast, 2 capsules after lunch, and 4 capsules after dinner, daily for duration of 28 days.
Control Intervention1: Not applicable: Not Applicable
Sponsors
Vidya Herbs Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male volunteers aged 40-70 years. 2. Body Mass Index (BMI) between 18.5 and 24.9 kg/m². 3. Stable medication regimen for at least 3 months prior to the study (if applicable). 4. Agrees to comply with the study protocol and procedures. 5. Agrees to not participate in any other clinical trials during the course of this trial. 6. Willing to participate in the study and provide informed consent.
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to fish oil or astaxanthin. 2. Current use of other investigational drugs. 3. Use of omega-3 supplements or astaxanthin supplements within 4 weeks prior to the study. 4. Significant liver or renal disease. 5. History of major cardiovascular events (e.g., myocardial infarction, stroke) within the last 6 months. 6. Active malignancy or history of cancer within the last 5 years. 7. Pregnant or lactating women and women of childbearing potential not following adequate contraceptive measures or women who were found positive for urine pregnancy test. 8. Participation in another clinical trial within 30 days prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in safety parameters including Complete Blood Count (CBC), Blood biochemistry, Lipid profile, Liver Function Tests (LFT) and Renal Function Tests (RFT)Timepoint: Day 1, Day 14, Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in vital signs parametersTimepoint: Day 1, Day 14, Day 28;2) Assessment of tolerability, incidence and severity of adverse eventsTimepoint: Day 1, Day 14, Day 28 | — |
Countries
India
Contacts
Public ContactDr Sudeep
Vidya Herbs Pvt Ltd
Outcome results
None listed